NCT00701207

Study of Nicotine Patches in Patients With Sarcoidosis

Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Elliott Crouser MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare peoples with disease (sarcoidosis) to those without disease. We want to see if people with sarcoidosis have a different immune response to those people without disease. The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis.

Detailed description

Until recently, there was no good explanation for the fact that smoking cigarettes actually reduces the risk of sarcoidosis. Research studies have shown that the nicotine, a common component of cigarette smoke, strongly suppresses the immune system and reduces the type of inflammation that is characteristic of sarcoidosis in the lungs. We propose that nicotine treatment, administered in the form of a skin patch, will reduce the severity of lung disease in patients with sarcoidosis. Sarcoidosis patients who volunteer to participate in this study will submit standardized questionnaires relating to their quality of life and the severity of their shortness of breath before and after treatment. We will also compare objective measures of lung function, radiographic parameters, and the severity of lung inflammation. We predict that nicotine treatment will reduce the severity of sarcoidosis symptoms, improve lung function, and resolve lung inflammation. If our hypothesis is proven to be correct in this relatively small group of patients, we will perform additional studies in a larger group of patients and will consider the features of sarcoidosis patients that predict a favorable response to nicotine and other nicotine-like drugs. If nicotine is ultimately found to be an effective treatment for sarcoidosis, it may replace some of the existing treatments which are frequently ineffective and have unacceptable side-effects.

Conditions

• Pulmonary Sarcoidosis

Interventions

Type	Name	Description
DRUG	nicotine patch	daily transdermal patch 7 mg, 14mg, 21 mg. 3 months

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-12-31
• Completion: 2010-12-31
• First posted: 2008-06-19
• Last updated: 2021-11-08

Locations

1 site across 1 country: United States